Displaced Femoral Neck Fracture in Elderly Patient. Should Cement be Used for Hip Hemiarthroplasty ?
NCT ID: NCT01787929
Last Updated: 2023-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
170 participants
INTERVENTIONAL
2016-02-07
2020-03-11
Brief Summary
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150 patients will be included, 75 with cemented hemiarthroplasty and 75 with uncemented hemiarthroplasty. They will be followed during one year after the surgery, with a functionality assessment at 3 month and 12 month.
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Detailed Description
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Prosthetic replacement has been favored for the treatment of displaced femoral neck fractures in the frail, elderly population with multiple medical comorbidities because of the challenges of achieving stable proximal fragment fixation in osteopenic bone, and the need for early, full weight-bearing mobilization. Failure rates of 30% to 40% have been consistently reported over multiple series over the past few decades in elderly patients with displaced femoral neck fractures treated with internal fixation.
Once prosthetic arthroplasty has been chosen, further controversy surrounds the type of fixation, cemented or cementless. Good to excellent results can be expected with either cemented or cementless newer generation arthroplasties. Risks of cementless arthroplasty include femoral fracture, prosthesis subsidence, and anterior thigh pain. Cementation of the prosthesis places the patient at risk for intraoperative death or embolization of marrow content during cementation.
The aim of the study is to assess the clinical relevance of a collared uncemented stem compared with use of cemented stem in elderly population with displaced femoral neck fracture.
A randomised trial will include 150 patients with an acute displaced femoral neck fracture in an elderly population. All patient will give informed consent, and the research protocol is approved by the regional ethics committee. The inclusion criteria are an age of at least 70 years old, a displaced femoral neck fracture (Garden stage III or IV), an ASA grade\< 4, ambulatory and non cognive impairment patients. Clinical and radiographic examinations will be perform at perioperative period, at 3 and 12 month after surgery. The main outcome measures will be functional score, pain, mobility, complications, reoperations, activity of daily living, quality of life, strenght, and radiolographic subsidence.
The primary hypothesis of this study is that use of a collared uncemented stem would not provide an improvement in functional outcome compared with use of cemented stem in elderly population with displaced femoral neck fracture.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Cemented hemiarthroplasty
hemiarthroplasty surgery with cement for displaced femoral neck fractures
hemiarthroplasty for displaced femoral neck fractures
Hemiarthroplasty is a surgery for displaced femoral neck fractures
Uncemented hemiarthroplasty
hemiarthroplasty surgery without cement is a surgery for displaced femoral neck fractures
hemiarthroplasty for displaced femoral neck fractures
Hemiarthroplasty is a surgery for displaced femoral neck fractures
Interventions
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hemiarthroplasty for displaced femoral neck fractures
Hemiarthroplasty is a surgery for displaced femoral neck fractures
Eligibility Criteria
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Inclusion Criteria
* 70 year old or more
* ASA score \< or = III
* Lee score \< or = 2
Exclusion Criteria
* pathological femoral neck fracture ( paget disease or tumor)
70 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Principal Investigators
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Regis BERNARD DE DOMPSURE, MD
Role: PRINCIPAL_INVESTIGATOR
University Nice Hospital
Locations
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orthopedics department, University Hospital
Nice, , France
Countries
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Other Identifiers
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12-PP-10
Identifier Type: -
Identifier Source: org_study_id
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